The efficacy of raltegravir plus optimized background therapy (OBT) has been demonstrated for antiretroviral (ARV)-experienced HIV-1-infected patients in randomized clinical trials. We studied viro-immunological response, pharmacokinetic parameters and genotypic test results in an observational cohort of multiple ARV class-experienced patients starting a raltegravir-based regimen.Methods
Already enrolled ANRS CO3 Aquitaine Cohort patients with virological failure were included in this study after starting a raltegravir-based regimen (400 mg twice a day, week 0). Virological success was defined by the plasma HIV-1 RNA level [viral load (VL)] <2.7 log10 copies/mL at week 12 and <1.7 log10 copies/mL at week 24. One patient was excluded from further analysis (no follow-up after week 4).Results
Fifty-one patients [male/female=43/8, median age=48 (interquartile range=43, 55) years] were included. At week 0, median CD4 count was 244 (110; 310)/mm3 and median VL was 4.2 (3.6, 4.7) log10 copies/mL. At week 24, 39 (78%) patients experienced virological success: 4 (44%), 14 (82%) and 21 (87%) patients with a genotypic sensitivity score <1, ≥1 and <2 and ≥2 (P=0.02), respectively. Raltegravir-related mutations emerged in 9 of 11 failing patients (82%): Q148H/R (n=5), N155S/H (n=3) and S230N (n=1). Median CD4 increases from week 0 to week 4 and week 24 were 28 (−4, 85) and 57 (0, 156) cells/mm3, respectively. A poor immune response was independently associated with a lower VL decline (week 0 to week 12) [odds ratio (OR): 3.5, 95% confidence interval (CI): 1.4, 8.4, for 1 log10 less] and CD4+% at baseline (OR: 2.6, 95% CI: 0.97, 8.3, for 10% lower).Conclusions
Raltegravir plus OBT provided a good virological success rate in highly pre-treated patients under clinical routine conditions.